An international, multicenter, two-stage optimal Simon's design, single-arm phase II clinical trial to evaluate zongertinib plus fulvestrant combination therapy in participants with hormone receptor-positive/HER2-negative advanced breast cancer harboring HER2 mutations.
Participant, or legal representative (if applicable), must be capable to understand the purpose of the Study and have signed written informed consent form (ICF) prior to beginning specific protocol procedures.
Female or male participants ≥ 18 years of age at the time of signing ICF.
Pre- or perimenopausal women and men provided they are being treated with a LHRH analogue for at least 28 days (if shorter, post-menopausal levels of serum estradiol/follicle-stimulating hormone [FSH] must be confirmed analytically) prior to initiation of the Study treatment, or post-menopausal women.
Histologically- or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either unresectable locally advanced or metastatic disease confirmed by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent.
Participation in another clinical trial, interventional or observational, until the Study's safety visit. Note: Participation in retrospective studies or data analysis is allowed.
Treatment with any approved or investigational cancer therapy within 21 days or 5 half-lives (whichever is shorter) prior to initiation of Study treatments, except for fulvestrant, which may be administered within a shorter interval.
Participants who must or wish to continue the intake of restricted medication or any drug considered likely to interfere with the safe conduct of the trial.
Known active uncontrolled or symptomatic central nervous system (CNS) metastases and/or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth.
Single group
Zongertinib (BI 1810631)
Drug120 mg of zongertinib orally once daily
Fulvestrant
Drug500 mg of fulvestrant IV on days 1 and 15 of the first cycle and once monthly thereafter
Investigator-assessed objective response rate (ORR).
To evaluate the investigator-assessed objective response rate (ORR) defined as the rate of participants with complete response (CR) or partial response (PR), as determined locally by the investigator using RECIST v.1.1 in all participants.
Investigator-assessed progression-free survival (PFS)
To assess the efficacy in terms of PFS, defined as the period from treatment initiation to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined locally by the Investigator using RECIST v.1.1 in all participants.
Clinical benefit rate (CBR)
To assess the efficacy in terms of CBR, defined as the rate of participants with objective response (CR or PR), or stable disease for at least 24 weeks, as determined locally by the investigator using RECIST v.1.1in all participants.
Time to response (TTR)
To assess the efficacy in terms of TTR, defined as the period from treatment initiation to the first objective tumor response (tumor shrinkage of ≥ 30%) observed for participants who achieved a CR or PR, as determined locally by the investigator using RECIST v.1.1 in all participants.
Duration of response (DoR)
To assess the efficacy in terms of DoR, defined as the period from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, as determined locally by the investigator using RECIST v.1.1 in all participants.
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MedSIR
Lead sponsor
Boehringer Ingelheim
Collaborator
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